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Global R&D Organization Places Order for Enhanced SEND Software Solution Suite

Instem Selected to Provide SEND Solution with Integrated Cross-Study Search and Browsing Capabilities

CONSHOHOCKEN, PA - (BUSINESS WIRE) – May 29, 2013 - - Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that another of the world’s leading healthcare companies has purchased their submit™ solution suite to support CDISC’s Standard for Exchange of Nonclinical Data (SEND).

SEND defines the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and contract research organizations and for submission to the US Food and Drug Administration (FDA).

Instem will also be providing the client with a comprehensive Data Integration & Bioinformatics solution, powered by its SRS™ technology. Using SRS, the client will be able to access, integrate and query SEND data being created from their own preclinical data collection system as well as SEND data received from their external study partners. This cross-study search and browsing capability will enable them to identify patterns and trends in their data, generating new knowledge and actionable insight.

Key Facts

  • Global R&D client purchases Instem’s complete submit software solution suite to create and manage SEND datasets throughout their lifecycle
  • SEND solution suite to include secure, 21 CFR Part 11 compliant dataset storage
  • Instem software to reduce client time and effort by translating study data to controlled terminology and automatically checking against SEND guidelines to ensure compliance
  • Instem’s SENDView™ solution for simplified data review part of submit delivery package

“It’s terrific to see industry embrace SEND and continue to turn to Instem for solutions that allow CRO’s, study partners and regulators to share, visualize and analyze study data more efficiently,” comments John Anderson-Carter, VP Sales at Instem. “We are especially encouraged to see this client take that extra step and leverage our comprehensive Data Integration & Bioinformatics technology platform to further enhance the SEND data sets providing valuable intelligence in their mission to reduce suffering and improve the quality of life.”

Instem has been providing industry education and outreach to promote SEND while demonstrating its own technology solution suite – submit. During 2012 Instem was recognized at the CDISC Interchange North America meeting for its outstanding contributions toward the completion of the SEND 3.0 Implementation Guide.

On May 16, 2013, Instem received the VOLTAGE Technology Innovator Award for its submit-SEND solution at a ceremony in Philadelphia. The VOLTAGE awards program, sponsored by SmartCEO magazine and Comcast, celebrates the role that technology plays in the business community and the future impact the technology sector will have on economic growth. Instem’s submit solution was also featured in the May edition of SmartCEO magazine.

Instem recently announced its strategic move into the early phase clinical trials market. Its expanded reach will additionally be providing a richer source of essential research and submission data to client Regulatory Affairs departments through a single common toolset using its submit suite.

About Instem

Instem is a leading supplier of IT applications to the early development healthcare market, delivering compelling solutions for data collection, management and analysis across the R&D continuum. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.

Instem’s portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.

Instem supports over 400 clients through full service offices in the United States, United Kingdom and China with additional locations in India and a full service distributor based in Japan.

Meeting clients at the intersection of investment & return™.

Press Contacts:

Gary Mitchell (US HQ)
Tel: 610-941-0990

Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600